FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
06/19/1990
FDA Enforcement for the week of June 20, 1990
FDA ENFORCEMENT REPORT
FOR JUNE 20, 1990
June 20, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
NONE
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COSMETICS
NONE
HUMNA DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Muromonab-CD3 Orthoclone OKT3 Sterile Solution,
5 mg (1 mg/1ml), for IV use only. Recall #B-149-0.
Code: Lot numbers: 19B007 EXP 11/89, 19D014 EXP 12/89,
68K111 EXP 7/89, 68L116 EXP 8/89, 68N129 EXP 9/89.
Manufacturer: Ortho Pharmaceutical Corporation, Biotech Division,
Raritan, New Jersey.
Recalled by: Manufacturer, by telephone between August 7, 1989 and
December 18, 1989. Firm-initiated recall complete.
Distribution: Nationwide, Japan, Mexico, Switzerland.
Quantity: Firm estimates none remains on market.
Reason: Product failed to maintain stability throughout the
approved dating period.
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Class III -
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Exactech Blood Glucose Testing System, consisting of
Blood Glucose Sensor and Blood Glucose test strips:
(a) Catalog #97100, Contains Blood Glucose Sensor;
Disposable Lancets, Lancing Device, Travel Case,
User's Manual;
(b) Catalog #97134, Contains Blood Glucose Sensor,
Blood Glucose Test Strips, Disposable Lancets,
Lancing Device, Travel Case, User's Manual;
(c) Catalog #97131, Exactech Hospital Pack -
Contains Blood Glucose Sensor, User's Manual.
Recall #Z-493/495-0.
Code: Lot numbers 1-198 and H-079.
Manufacturer: Medisense, Inc., Cambridge, Massachusetts
Recalled by: Manufacturer, by letter on or about January 24, 1990
and June 6, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide and international.
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Quantity: 41,536 systems were distributed.
Reason: The user's manual did not explain that the "ERR" message
may indicate that the user's blood glucose level may have
exceeded the electronic capability of the sensor.
----
Product: Hawkins Breast Localization Needles:
(a) Catalog No. 253125, Hawkins Breast Localization
Needle, Version III, needle length 12.5 cm, sterile;
(b) Catalog No. 253075, Hawkins Breast Localization
Needle, Version III, needle length 7.5 cm sterile.
Recall #Z-650/651-0.
Code: Lot numbers: (a) 00521082; (b) 92280182.
Manufacturer: National-Standard Medical Products Company,
Gainesville, Florida.
Recalled by: Manufacturer, by telephone May 7, 1990. Firm-initiated
recall ongoing.
Distribution: (a) Tennessee; (b) Arkansas.
Quantity: 20 units were distributed.
Reason: Opened packages with defective pouch seals which may
compromise sterility.
----
Product: Fernoplex Ambulance Cot, Model 28, used for transporting
patients and has a load capacity of 4100 pounds.
Recall #Z-653-0.
Code: Lot Numbers: Serial Numbers
M472460 L53573, L53575, L53576, L53577, L53578,
L53580, L53581, L53582, L53583;
M501730 L54371 through L54381;
M526340 L55740 through L55747;
M549030 L56956 through L56963;
M565260 L57440, L57441, L57443 through L57450;
M580340 L59076 through L59087.
Manufacturer: Ferno-Washington, Inc., Wilmington, Ohio.
Recalled by: Manufacturer, by letter March 7, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 58 cots were distributed.
Reason: A design change was made, consisting of placing a rolling
cam on the shaft which serves as the bearing for the
bracket. However, the first 66 cots manufactured after the
design modification were assembled without the rolling cam.
----
Product: Ohmeda check valve disc retainer:
(a) Ohmeda GMS Absorber, Double Canister Model,
Stock #309-0170-800;
(b) Ohmeda GMS Absorber, Single Canister Model,
Stock #309-0171-800;
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(c) Ohmeda GMS Absorber, Double Canister ISO Model,
Stock #1400-8002-000;
(d) Ohmeda Check Valve Disc Retainers, Stock #0219-1338-300.
Recall #Z-657/660-0.
Code: All Ohmeda GMS Abosbers that have a ALPHA serial number of
"ACL------" (all serial numbers contain a total of nine
digits).
Manufacturer: Ohmeda, Madison, Wisconsin.
Recalled by: Manufacturer, by letter June 1, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 13,990 units were distributed.
Reason: The inhalation and/or exhalation check valve retainers
may become dislodged on the Ohmeda GMS Absorbers allowing
patient rebreathing to occur.
----
Product: Stryker Fold Down Siderails, catalog #399-31 and #940-32
which may have been used on the following Stryker beds and
stretchers: Model 911 Transcare, Model 915 Transcare,
Model 916 Gurney, Model 917 Gurney; Model 920/921 Insta Care;
Model 930/931/932/933 Consta Care; Model 935/936/937 Surgi
Care; Model 940 Surgibed; Model 942 LTD Series; Model 960
Surgibed; Model 962 Surgibed; Model 974/976 VIP Table.
Recall #Z-661/662-0.
Code: All fold-down siderails manufactured prior to
January 1985.
Manufacturer: Stryker Corporation, Medical Division, Kalamazoo, Michigan.
Recalled by: Manufacturer, by maintenance alert May 1988. Firm-
initiated field correction complete.
Distribution: Nationwide.
Quantity: Firm estimates as many as 2,500 units remain on market.
Reason: The siderails could collapse completely and cause injury
to patients or hospital staff.
----
Product: Beacon Laboratories B-100 Argon Coagulator Disposable
Footcontrol Pencil with 10 ft. Cord, a single-use, sterile,
electrosurgical prescription device, used in the operating
room during patient surgery. Recall #Z-666-0.
Code: Catalog #4010, Stock #03002-001, Lot #935201.
Manufacturer: Beacon Laboratories, Inc., Broomfield, Colorado.
Recalled by: Manufacturer, by letter February 12, 1990. Firm-initiated
recall ongoing.
Distribution: Michigan, New Jersey, Alabama, Nebraska, Colorado.
Quantity: 230 units were distributed; firm estimates 44 units
remain on market.
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Reason: Some of the package seals were found to be wrinkled
which may compromise the sterility of the product.
In addition two units were noted to be missing electrical
parts (banana plugs).
----
Product: Reusable Single Patient Self-Adhesive Electrodes with
Snap Connectors for neuromuscular stimulation, an Rx
device designed to be connected to lead wires of a
battery powered transcutaneous electrical nerve stimulator,
which disperses electrical charges from the instrument.
distributed under the Versa-Stim and Eas-E-Stim labels.
Recall #Z-669-0.
Code: All lot numbers.
Manufacturer: Conmed Corporation, Utica, New York.
Recalled by: Manufacturer, by telephone May 16, 1990 followed by
letter May 17, 1990. Firm-initiated recall ongoing.
Distribution: Illinois, Indiana, Kansas, Missouri, Florida, Texas,
Arizona, Oregon, California, Pennsylvania, New Hampshire,
North Carolina, The Netherlands.
Quantity: 1,289 cases (4 electrodes per envelope, 10 envelopes
per box, 2 boxes per case) were distributed; firm
estimates 50 percent remains on market.
Reason: Labeling did not warn users that the device is intended
for use with battery powered T.E.N.S. devices only.
----
CORRECTION: Software Revision LVP36F-Intelligent (infusion) Pump
Model No. 521, Recall #Z-648-0 which appeared in the
June 13, 1990 Enforcement Report should read:
Quantity: 2,027 pumps with software version LVP36F
were distributed.
----
Class III -
Product: Marquest Medical Products Arterial Blood Gas Kit, used
for pH and blood gas analysis, for in-vitro diagnostic
use (for arterial puncture). Recall #Z-652-0.
Code: Lot 31554 EXP 1/92.
Manufacturer: Marquest Medical Products, Inc., Englewood, Colorado.
Recalled by: Manufacturer, by telephone April 17, 1990. Firm-initiated
recall ongoing.
Distribution: Ohio, Colorado, California, Virginia.
Quantity: 100 cases (10 per case) were distributed; firm estimates
20 cases remain on market.
Reason: The tip and plunger rod of the plastic barrel syringe
may separate.
----
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Product: Centocor CA 15-3 RIA Radioimmunoassay, an in-vitro
diagnostic kit used for the measurement of cancer antigen
15-3 in serum plasma. Recall #Z-654-0.
Code: 8K0609 JAN 1, 90; 8K0629 JAN 15, 90; 8K0659 FEB 6, 90;
8K0699 FEB 13, 90; 8K0020 MAR 10, 90; 8K0010 MAR 13, 90;
8K0040 MAR 21, 90; 8K0070 MAR 23, 90.
Manufacturer: Centocor, Inc., Malvern, Pennsylvania.
Recalled by: Manufacturer, by letter dated May 25, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada, Japan, England, The Netherlands.
Quantity: 1,635 kits were distributed.
Reason: Product standards are out of specifications. Degradation
resulted in patient serum levels to be biased by
approximately 11 percent to 14 percent higher than the
actual value.
----
Product: High Flow 50 Oxygen System, Product #406333, a portable
liquid oxygen device for providing a controlled rate of
oxygen flow to a patient. Recall #Z-656-0.
Code: All serial numbers.
Manufacturer: Cryogenic Associates, Medical Division of Minnesota,
Valley Engineering, Inc., New Prague, Minnesota.
Recalled by: Manufacturer, by telephone May 7, 1990 followed by
letter May 21, 1990. Firm-initiated recall ongoing.
Distribution: Colorado, Georgia, Maryland, Minnesota, Ohio,
Pennsylvania, Canada, France.
Quantity: 101 units were distributed.
Reason: The oxygen flow rate may be as much as 20 percent less
than the flow rate setting during the first half hour of use.
----
Product: Vacutainer brand Tube containing 0.1 molar buffered sodium
citrate, a blood collection tube. Recall #Z-667-0.
Code: Lot numbers: 9L019, Reorder #6418 and 9L020 Reorder #6419
EXP 6/91.
Manufacturer: Becton Dickinson, Broken Bow, Nebraska.
Recalled by: Becton Dickinson Vacutainer Systems, East Rutherford,
New Jersey, by telephone between March 7 and 9, 1990
followed by letter letters mailed between March 8 and 12,
1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, England.
Quantity: 302,000 tubes of lot 9L019 and 361,000 tubes of lot 9L020.
were distributed; firm estimates 3,808 tubes of lot 9L019
and 12,765 tubes of lot 9L020 remain on market.
Reason: Some of the tubes are contaminated with Tripotassium EDTA
(K3EDTA), which is another anticoagulant instead of the
intended anticoagulant, sodium citrate.
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VETERINARY PRODUCTS
NONE